Antimicrobial inserts for stopcock medical connectors

ABSTRACT

Various embodiments of an antimicrobial insert for a stopcock medical connector are provided. More specifically, the present invention relates to an antimicrobial insert that is seated within at least a portion of the annular bore of the connector&#39;s tap, wherein fluid within the annular bore contacts the antimicrobial insert, thereby preventing microbial proliferation within the stopcock medical connector.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/606,829, filed Jan. 27, 2015, title ANTIMICROBIAL INSERTS FORSTOPCOCK MEDICAL CONNECTORS, which is incorporated herein in itsentirety.

BACKGROUND OF THE INVENTION

Infusion therapy generally involves the administration of a medicationintravenously. When performing a typical infusion therapy, one or moreinfusion therapy device (e.g. tubing sets, catheters, etc.) are commonlyused. In some instances, an infusion therapy device may include astopcock medical connector to permit selective administration of a fluidthrough the infusion therapy device. The stopcock medical connectorcomprises a housing in which is rotatably seated a tap. The tap includesone or more fluid pathways that may be aligned (i.e., the open position)or misaligned (i.e., the closed position) within the housing to permitor prevent a fluid from passing through the housing. Thus, whenadministration of fluid is desired, the tap is rotated from the closedposition to the open position to permit fluid to pass through thehousing and into the patient via the infusion therapy device.Conversely, the tap is rotated to the closed position when it is desiredto cease the administration of a fluid.

When in the closed position, fluid trapped within the fluid pathway ofthe stopcock medical connector remains stagnant. These stagnantconditions are ideal for growth and colonization of microbes, which maylead to subsequent microbial infection when the medical connector isopened and the fluid is infused into the patient.

Thus, while methods and systems currently exist for selectivelyadministering fluid to a patient via the use of a stopcock medicalconnector, challenges still exist. Accordingly, it would be animprovement in the art to augment or replace current techniques with thesystems and methods discussed herein.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to various antimicrobial stopcock medicalconnectors. More specifically, the present invention relates to anantimicrobial insert that is seated within at least a portion of theannular bore of the connector's tap, wherein fluid within the annularbore contacts the antimicrobial insert, thereby preventing microbialproliferation within the stopcock medical connector.

Some implementations of the present invention comprise a stopcockmedical connector having two or more ports coupled to a housing, thehousing further comprising a tap rotatably positioned therein. The tapfurther comprises one or more annular bores providing a pathway throughthe tap, wherein the tap may be rotated within the housing to align theone or more annular bores with the two or more ports of the housing,thereby providing fluid communication between two or more ports via theannular bores.

Some implementations of the present invention further comprise one ormore antimicrobial inserts that is placed within at least one of theannular bores so as to be in contact with a fluid passing through theannular bore. As such, fluid passing through the stopcock medicalconnector is exposed to the antimicrobial insert. In some instances, theantimicrobial insert comprises a polymer material having anantimicrobial coating applied to the outer surface of the antimicrobialinsert. In other instances, the antimicrobial insert comprises anantimicrobial material. Further, in some instances the antimicrobialinsert comprises a polymer material forming a matrix comprising aplurality of interstices in which antimicrobial material is loaded ordispersed and is therefore capable of eluting out of the polymermaterial when the antimicrobial insert is exposed to a fluid.

Some implementations of the present invention comprise an antimicrobialmaterial or coating having an antimicrobial agent selected from thegroup consisting of chlorhexidine diacetate, chlorhexidine gluconate,alexidine, silver sulfadiazine, silver acetate, silver citrate hydrate,cetrimide, cetyl pyridium chloride, benzalkonium chloride,o-phthalaldehyde, and silver element. In other implementations, theantimicrobial material or coating comprises two or more antimicrobialagents. In some embodiments, the antimicrobial material is mixed into acarrying material, such as an adhesive, that is used for bonding theantimicrobial insert within the annular bore of the stopcock.

The antimicrobial insert of the present invention generally comprises astructure that is capable of being inserted and retained within theannular bore of the stopcock connector tap. In some instances, theantimicrobial insert comprises an annular shape having an outer diameterthat is approximately equal to the inner diameter of the annular bore inwhich it is seated. For example, in some instances the antimicrobialinsert comprises an outer diameter is approximately equal to thediameter of the annular bore, such that the antimicrobial insert isretained within the annular bore via a friction fit.

In some instances, the antimicrobial insert comprises a resilientpolymer material having an initial, non-annular shape that is capable ofbeing forced into the annular bore. Once inserted, the non-annular shapeconforms to the annular shape of the annular bore and provides increasedmechanical and frictional force on the annular bore as the resilientpolymer material tries to resume its non-annular shape.

Some implementations of the present invention further comprise anantimicrobial insert comprising a plurality of interconnected structuralmembers forming a grid-like structure forming a plurality of windows. Anouter circumference of the grid-like structure is approximately equal tothe diameter of the annular bore such that the antimicrobial insert iscapable of being inserted therein. The grid-like structure furtherprovides increased surface area as it is capable of extending throughoutthe entire length of the annular bore. The plurality of windows permitsfluid to flow freely through the grid-like structure withoutcompromising or reducing fluid flow. In some instances, the grid-likestructure comprises a resilient polymer material whereby theantimicrobial insert is capable of being forced into the annular boreand maintained in its position through mechanical and frictional forces.

Some implementations of the present invention further include a stopcockmedical connector comprising a tap having two or more annular bores, andfurther comprising two or more antimicrobial inserts positioned therein.

Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be obvious from thedescription, or may be learned by the practice of the invention. Thefeatures and advantages of the invention may be realized and obtained bymeans of the instruments and combinations particularly pointed out inthe appended claims. These and other features of the present inventionwill become more fully apparent from the following description andappended claims, or may be learned by the practice of the invention asset forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1 shows a perspective view of a three-way antimicrobial stopcockmedical connector in accordance with a representative embodiment of thepresent invention.

FIG. 2 shows a cross-section side view of an antimicrobial stopcockmedical connector in an open position in accordance with arepresentative embodiment of the present invention.

FIG. 3 shows a cross-section side view of an antimicrobial stopcockmedical connector in an open position in accordance with arepresentative embodiment of the present invention.

FIG. 4 shows a perspective, exploded view of 3-way antimicrobialstopcock medical connector in accordance with a representativeembodiment of the present invention.

FIG. 5 shows a perspective view of an antimicrobial insert comprising aresilient polymer material and having a non-annular shape, wherein theantimicrobial insert assumes a temporary annular shape as it is forcedinto the annular bore of a tap and is maintained within the annular borethrough frictional and mechanical forces in accordance with arepresentative embodiment of the present invention.

FIG. 6 shows a perspective view of an antimicrobial insert in accordancewith a representative embodiment of the present invention.

FIG. 7 shows a perspective view of a stopcock tap comprising an annularbore in which is seated the antimicrobial insert shown in FIG. 6, inaccordance with a representative embodiment of the present invention.

FIG. 8 shows a cross-section top view of the stem portion of thestopcock tap shown in FIG. 7, wherein one annular bore of the 3-wayantimicrobial stopcock medical connector is fitted with theantimicrobial insert of FIG. 6, and an intersecting annular bore of the3-way antimicrobial stopcock medical connector is shown ready to receivea shortened or truncated antimicrobial insert of FIG. 6 in accordancewith a representative embodiment of the present invention.

FIG. 9 shows an exploded view of a 3-way antimicrobial stopcock medicalconnector comprising a stopcock tap having a recessed, annular surfacefor receiving an antimicrobial ring in accordance with a representativeembodiment of the present invention.

FIG. 10 shows a perspective view of the assembled 3-way antimicrobialstopcock medical connector shown in FIG. 9 in accordance with arepresentative embodiment of the present invention.

FIG. 11 shows a perspective top view of the 3-way antimicrobial stopcockmedical connector shown in FIG. 9, wherein the stopcock tap has beenrotated to close the fluid path to the side port in accordance with arepresentative embodiment of the present invention.

FIG. 12 shows a side plan view of the 3-way antimicrobial stopcockmedical connector shown in FIG. 11, wherein the side port has beenremoved to provide a partial cross-section view into the housing inaccordance with a representative embodiment of the present invention.

FIG. 13 shows a cross-section side view of the 3-way antimicrobialstopcock medical connector shown in FIG. 11 in accordance with arepresentative embodiment of the present invention.

FIGS. 14A and 14B each show a perspective top view of an antimicrobialring in accordance with representative embodiments of the presentinvention.

FIG. 15 shows an exploded view of a 3-way antimicrobial stopcock medicalconnector comprising an antimicrobial ring having bores configured toreceive antimicrobial inserts in accordance with a representativeembodiment of the present invention.

FIGS. 16A and 16B each show a perspective view of the assembled 3-wayantimicrobial stopcock medical connector of FIG. 15 in accordance withrepresentative embodiments of the present invention.

FIG. 17 shows a perspective view of the antimicrobial ring of FIG. 15 inaccordance with a representative embodiment of the present invention.

FIG. 18 shows a cross-section side view of the 3-way antimicrobialstopcock connector of FIG. 16 in accordance with a representativeembodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to various antimicrobial stopcock medicalconnectors. More specifically, the present invention relates to anantimicrobial insert that is seated within an annular bore of theconnector's tap, wherein fluid within the annular bore contacts theantimicrobial insert, thereby preventing microbial proliferation withinthe stopcock medical connector.

Referring now to FIG. 1, a perspective view of a stopcock medicalconnector 10 is shown. Stopcock medical connector 10 comprises a housing20 generally having a tubular shape. Housing 20 comprises an opening orproximal end 22 that is sized to compatibly receive tap 30. In someinstances, housing comprises a side port of an intravenous device, suchas a catheter adapter. Housing 20 further comprises a closed or distalend 24 that is located opposite opening 22, wherein housing 20 comprisesa lumen 26 extending between proximal and distal ends 22 and 24, asshown in FIG. 2. In some instances, distal end 24 further provides aseat surface 27 that is configured to support tap 30 when seated withinlumen 26.

Referring now to FIGS. 1 and 2, in some instances housing 20 furthercomprises one or more ports that are connected to housing 20 and influid communication with lumen 26. For example, in some embodimentshousing 20 comprises an upstream port 40 and a downstream port 50.Housing 20 may further comprise a side port 60 to provide a 3-waystopcock medical connector. Embodiments of the present invention mayalternatively comprise a 2-way stopcock medical connector.

Ports 40, 50 and 60 each comprise a hollow interior, 42, 52, and 62,respectively, which is in fluid communication with lumen 26. The freeends of ports 40, 50 and 60 may be coupled to an intravenous device,such as a section of intravenous tubing, or a syringe. Fluid within anyof the ports may pass into another port by passing through annular bore32 of tap 30. For example, fluid within upstream port 40 may flow intodownstream port 50 via annular bore 32 when annular bore 32 is alignedwith, and in fluid communication with ports 40 and 50. Similarly, fluidwithin upstream port 40 may flow into side port 60 when annular bore 32is either aligned with, and in fluid communication with the ports 40 and60. In some embodiments, annular bore 32 further comprises a secondarybore 33 (shown in FIGS. 4, 7 and 8) that intersect with, and is in fluidcommunication with annular bore 32. As such, fluid within upstream port40 may flow into side port 60 when each of annular bore 32 and secondarybore 33 are in fluid communication with one of ports 40 and 60.Alignment of annular bore 32, secondary bore 33, and ports 40, 50 and 60is achieved by rotating tap 30 within lumen 26, as is common to theoperation of stopcock medical connectors.

Embodiments of the present invention further comprise an antimicrobialinsert that is configured for insertion within one or more annular boresof tap 30. An antimicrobial insert is generally positioned within one ormore annular bores of tap 30 so as to be in contact with a fluid that ispresent within, or passing through the one or more annular bores. Assuch, the antimicrobial insert kills microorganisms or inhibits theirgrowth within the fluid.

The antimicrobial insert may comprise any compatible material. In someinstances, an antimicrobial insert comprises a non-porous polymermaterial having an antimicrobial coating applied to the outer surface ofthe insert, wherein the antimicrobial coating comprises an antimicrobialagent that is safe for use in accordance with the teachings of thepresent invention. In other instances, an antimicrobial insert comprisesa porous polymer material having an antimicrobial coating applied to theouter surface and infused within the porous structure of the insert,wherein the infused portion of the antimicrobial coating is capable ofleaching out of the insert's porous structure to provide a zone ofinhibition around the insert. Further still, in some instances anantimicrobial insert comprises a polymer material that is prepared incombination with an antimicrobial agent, whereby the final materialcomprises antimicrobial properties. Thus, the final material exhibitsantimicrobial activity through direct contact with a fluid.

Some antimicrobial coatings of the present invention comprise one ormore antimicrobial agents that are compatible for intravenous use. Forexample, in some instance an antimicrobial agent is selected from thegroup consisting of chlorhexidine diacetate, chlorhexidine gluconate,alexidine, silver sulfadiazine, silver acetate, silver citrate hydrate,cetrimide, cetyl pyridium chloride, benzalkonium chloride,o-phthalaldehyde, and silver element. In some instances, theantimicrobial coating comprises two or more antimicrobial agents.

In some embodiments, the antimicrobial insert comprises an insoluble,cured antimicrobial coating. In other instances, the antimicrobialinsert comprises a cured coating that is softened when exposed to fluid,thereby eluting a portion of the antimicrobial agent into the fluid. Inother instances, the antimicrobial insert comprises a solubleantimicrobial coating that slowly dissolves upon prolonged exposure to afluid.

In other instances, the final material of the antimicrobial insertelutes antimicrobial agent when contacted by a fluid, thereby providinga zone of inhibition surrounding the material. For example, in someembodiments an antimicrobial insert comprises a UV cured, hydrophilicpolymer material that forms a matrix comprising a plurality ofmicroscopic interstices in which an antimicrobial agent is dispersed orloaded. Upon exposure to fluid, the polymer matrix is softened andpenetrated by the fluid. The antimicrobial agent within the polymermatrix is eluted out of the matrix and into the fluid to form a zone ofinhibition in proximity to the polymer matrix. Examples of suitablepolymer materials are provided in U.S. patent application Ser. Nos.12/397,760, 11/829,010, 12/476,997, 12/490,235, and 12/831,880, each ofwhich is incorporated herein in their entireties.

With specific reference to FIGS. 2 and 3, stopcock medical connector 10is shown with antimicrobial inserts 100 seated within a portion ofannular bore 32. Antimicrobial inserts 100 may comprise any shape,cross-sectional shape, or size that is compatible for use in stopcockmedical connector 10. As shown, in some embodiments antimicrobialinserts 100 comprise an annular ring having an outer diameter that isapproximately equal to, or slightly larger than the diameter of annularbore 32, wherein antimicrobial inserts 100 are retained within annularbore 32 via a friction fit. In other instances, inserts 100 are retainedwithin annular bore 32 via an adhesive.

In some instances, ports 40 and 50 comprise a narrowed diameter 44 and54, respectively, which is smaller than the diameter of annular bore 32.For some embodiments, narrowed diameters 44 and 54 are approximatelyequal to an inner diameter of antimicrobial insert 100. As such,narrowed diameters 44 and 54 do not affect the flow of fluids throughantimicrobial insert 100 and annular bore 32. Narrowed diameters 44 and54 provide physical barriers to prevent displacement of antimicrobialinserts 100 into hollow interiors 42 and 52 of ports 40 and 50,respectively.

In some embodiments, annular bore 32 further comprises a stepped surface34 that is flanked by antimicrobial inserts 100, as shown in FIG. 3.Stepped surfaces 34 provide channels 36 having a width configured toreceive antimicrobial insert 100. In some instances, narrowed diameters44 and 45 and stepped surfaces 34 combined to provide channels 36.Generally, stepped surfaces 34 have a height that is approximately equalto the cross-sectional thickness of antimicrobial insert 100. As such,the inner diameter of annular bore 32 at stepped surfaces 34 isapproximately equal to the inner diameter of antimicrobial inserts 100.In this way, the passageway through tap 30, as defined by the innerdiameter of antimicrobial inserts 100 and the inner diameter of annularbore 32 at stepped surfaces 34 is constant, and comprises a volume ordiameter selected to provide a desired flow rate.

Referring now to FIG. 4, an exploded view of tap 30 and housing 20 isshown. In some instances, separate antimicrobial inserts 100 areprovided for each annular bore of tap 30. For example, in some instancestap 30 comprises a pair of antimicrobial inserts 100 are inserted withinannular bore 32 and a second antimicrobial insert 101 inserted withinsecondary annular bore 33. As such, fluid within housing 20 or tap 30 isin contact with at least one antimicrobial insert 100 regardless of therotational position of tap 30.

Referring now to FIG. 5, an antimicrobial insert 150 is shown. In someembodiments, antimicrobial insert 100 comprises an outer surface 151having a convex surface with a radius that is approximately equal to, orequal to the radius of the outer surface of tap 30. As such, outersurface 151 and the outer surface of tap 30 provide a uniform surface ina common radial plane. In some instances, an inner surface 153 ofantimicrobial insert 100 is planar. In other instances, inner surface153 comprises a concave surface with a radius that is approximatelyequal to, or equal to the radius of the inner surface of tap 30.

In some instances, antimicrobial insert 150 comprises a resilientpolymer material having an initial, non-annular shape that is capable ofbeing forced into annular bore 32 of 30. Once inserted, the non-annularshape conforms to the annular shape of annular bore 32. The resilientforces within antimicrobial insert 150 provide increased mechanical andfrictional force on annular bore 32 as the deformed antimicrobial insert150 tries to resume its initial, non-annular shape. These increasedmechanical and frictional forces maintain the position of antimicrobialinsert 150 within annular bore 32 without requiring an adhesive or otherretaining mechanism or structure.

Referring now to FIG. 6, an antimicrobial insert 200 is shown.Antimicrobial insert 200 comprises a monolithic structure forming aframework of interconnected segments 210. A plurality of windows 220 isprovided between each of the interconnected segments 210, whereby theplurality of windows 220 provides a plurality of fluid pathways throughand around the interconnected segments 210. In some instances,antimicrobial insert 200 comprises a central axis 230 running the entirelength of antimicrobial insert 200. Central axis 230 further comprises aplurality of nodes 240 spaced between the proximal and distal ends ofcentral axis 230, wherein the plurality of nodes 240 comprise a rigidjoint of joined segments 210.

In some instances, antimicrobial insert 200 comprises a diameter 250that is approximately equal to, or slightly smaller than the diameter ofannular bore 32. As such, antimicrobial insert 200 is slidably insertedand retained within annular bore 32 in the same fashion as withantimicrobial insert 100. Antimicrobial insert 200 may comprise anymaterial and/or coating in accordance with the present invention. Forexample, in some instances antimicrobial insert 200 comprises a polymermaterial having an antimicrobial coating applied to an outer surface ofthe insert. In other instances, antimicrobial insert 200 comprises anantimicrobial material. Antimicrobial insert 200 may further comprise aresilient polymer material whereby insert 200 is capable of being forcedinto annular bore 32, whereby insert 200 is slightly deformed uponinsertion therein. In some instances, the forced-fit of antimicrobialinsert 200 provides increased mechanical and frictional forces betweeninsert 200 and annular bore 32, whereby the position of insert 200within annular bore 32 is maintained by these forces without requiringan adhesive or other mechanical structures.

Referring now to FIGS. 7 and 8, tap 30 is shown having antimicrobialinsert 200 inserted within annular bore 32. In some instances, tap 30comprises a single antimicrobial insert 200, wherein annular bore 34does not have an insert. In other instances, tap 30 comprises a firstantimicrobial insert 200 inserted within annular bore 32, and furthercomprises a truncated annular insert 202 inserted within annular bore34, as shown in the cross-section view of FIG. 8. Further, in someinstances annular bore 34 comprises more than two antimicrobial inserts.

Some embodiments of the present invention further include a stopcock tap130 comprising an annular recess 300 which encompasses annular bores 32and 34 and is configured to receive antimicrobial ring 400, as shown inFIGS. 9 and 10. Antimicrobial ring 400 comprises, or is comprised of anantimicrobial material in accordance with the previous discussion. Insome instances, antimicrobial ring 400 comprises a wall thickness thatis less than or equal to the depth of annular recess 300, whereinplacement of antimicrobial ring 400 within annular recess 300 providesstopcock tap 130 with a uniform outer diameter.

Antimicrobial ring 400 comprises fluid apertures 402, 404 and 406 thatare provided and configured to align with annular bores 32 and 34 wheninstalled within annular recess 300. In some instances, fluid apertures402, 404 and 406 comprise a cross-sectional area that is less than across-sectional area of annular bores 32 and 34 so as limit the rate offlow through annular bores 32 and 34. In other instances, fluidapertures 402, 404 and 406 comprise cross-sectional areas that are equalto or larger than the cross-sectional areas of annular bores 32 and 34.

In some instances, antimicrobial ring 400 comprises a slit 410 to permittemporary expansion of antimicrobial ring 400 for the purpose ofinstalling antimicrobial ring 400 within annular recess 300, as shown inFIGS. 9, 11, 12 and 14A. In some instances antimicrobial ring 400comprises a resilient or inflexible material, or alternatively aresilient, flexible material that comprises a continuous circumference,such as is shown in FIG. 14B. As thus configured, antimicrobial ring maybe temporarily deformed or stretched to be seated within annular recess300, wherein antimicrobial ring 400 is restored to its originalconfiguration once seated therein.

With continued reference to FIGS. 9 and 10, antimicrobial ring 400 maybe retained within annular recess 300 by any known method or means. Forexample, in some instances antimicrobial ring 400 is retained withinannular recess 300 via frictional and/or mechanical forces. In otherinstances antimicrobial ring 400 is retained within annular recess 300via an adhesive or epoxy. In some instances annular recess 300 furthercomprises a physical feature that interacts either with slit 410 or acomplimentary feature provided on the inner surface of antimicrobialring 400. In this manner, the interaction between the physical featureand antimicrobial ring 400 maintains a preferred rotational positioningof antimicrobial ring 400 within annular recess 300.

As with the previously discussed embodiments, the flow path of a fluidthrough stopcock medical adapter 10 may be selected by rotating stopcocktap 130 within housing 20 to align annular bore 32 with a desired port40, and/or 60. In some instances, stopcock tap 130 is rotated to aposition wherein bore 32 is aligned with upstream and downstream ports40 and 60, and misaligned with side port 50, as shown in FIGS. 11-13.Fluid apertures 402 and 406 are aligned with downstream port 60 andupstream port 40, respectively. Fluid aperture 404 is not aligned withany port, but rather is in contact with the inner surface of housing 20,as can be seen in FIG. 13. The proximity and contact between the portionof antimicrobial ring 400 proximate to port 40 and the inner surface ofhousing 20 prevents antimicrobial growth that may otherwise occur in thestagnant fluid located between these components and/or surfaces.Similarly, side port 50 is not aligned with any fluid apertures, butrather is in contact with a portion of antimicrobial ring 400 positionedbetween adjacent fluid apertures 402 and 406, as can be seen in FIGS. 12and 13. The proximity and contact between antimicrobial ring 400 andside port 50 prevents antimicrobial growth that may otherwise occur instagnant fluids between these components and/or surfaces. Antimicrobialring 400 therefore provides antimicrobial properties to any surface,interface, aperture, void, volume, or fluid in which it is in proximityand/or contact. Thus, depending upon the position of stopcock tap 130within housing 20, antimicrobial ring 400 may provide antimicrobialprotection to a plurality of surfaces, materials and fluids within, orpassing through stopcock medical adapter 10.

Referring now to FIGS. 16A-17, in some embodiments stopcock tap 430comprises oversized annular bores 432, 434 and 436. Oversized bores 432,434 and 436 each comprise an inner diameter configured to receive anantimicrobial insert 100 to achieve maximum antimicrobial elution. Insome instances, antimicrobial inserts 100 comprise a length that isgreater than the depth of the oversized bores. As such, whenantimicrobial inserts 100 are inserted within oversized bores 432, 434and 436, the outer or end face surfaces of inserts 100 protrudeoutwardly beyond annular recess 300. In some instances, antimicrobialring 400 comprises enlarged ports 452, 454, and 456 each comprising aninner diameter configured to receive the protruding surfaces ofantimicrobial inserts 100. In some instances, antimicrobial ring 400comprises a wall thickness that is approximately equal to the height ofthe protruding end face of antimicrobial inserts 100. Further, in someinstances the end faces of antimicrobial inserts 100 comprise a radiusthat is equal to, or approximately equal to the radius of the outersurface of antimicrobial ring 400. As such, when antimicrobial ring 400is inserted or fitted within annular recess 300, and inserts 100 arefitted within enlarged ports 452, 454, and 456, the end faces of inserts100 and the outer surface of antimicrobial ring 400 provide an evensurface in a uniform radial plane. In some instances, the inner facesurfaces of inserts 100 further comprise a radius that is equal to, orapproximately equal to the radius of the inner surface of stopcock tap430.

In some embodiments, oversized bores 432, 434 and 436 comprise an innerstop (not show) to prevent over-insertion of inserts 100. In someinstances, inserts 100 are fixedly secured within oversized bores 432,434, and 436 via an adhesive or a mechanical or friction fit. In otherinstance, inserts 100 are maintained within their respective bores dueto the minimal tolerance between the inner surface of housing 20 and theouter surface of antimicrobial ring 400 when tap 430 is inserted withinhousing 20, as shown in FIG. 18. In some instances, inserts 100 comprisean inner diameter configured to achieve a direct flow rate, as discussedpreviously.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. An antimicrobial insert device for placement within a fluid pathwayof a stopcock tap, wherein the antimicrobial insert is comprised of anantimicrobial material.
 2. The device of claim 1, wherein theantimicrobial insert is coated with an antimicrobial material.
 3. Thedevice of claim 1, comprising an annulus shape having an outercircumference defining an outer surface, and an inner circumferencedefining a fluid pathway through the antimicrobial insert.
 4. The deviceof claim 3, wherein the outer circumference is selected to compatiblyseat the antimicrobial insert within the fluid pathway of the stopcocktap.
 5. The device of claim 4, wherein the fluid pathway of the stopcocktap comprises an annular bore.
 6. The device of claim 1, comprising athree-dimensional matrix forming a frame structure and having aplurality of apertures.
 7. The device of claim 6, wherein the insert iscomprised of an antimicrobial material.
 8. The device of claim 6,wherein the insert is coated with an antimicrobial material.
 9. Thedevice of claim 1, further comprising an antimicrobial composition thateither comprises or coats the insert, wherein the antimicrobialcomposition is selected from the group consisting of chlorhexidinediacetate, chlorhexidine gluconate, alexidine, silver sulfadiazine,silver acetate, silver citrate hydrate, cetrimide, cetyl pyridiumchloride, benzalkonium chloride, o-phthalaldehyde, and silver element.